[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR316.27]

[Page 183]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 316--ORPHAN DRUGS--Table of Contents
 
                Subpart C--Designation of an Orphan Drug
 
Sec. 316.27  Change in ownership of orphan-drug designation.

    (a) A sponsor may transfer ownership of or any beneficial interest 
in the orphan-drug designation of a drug to a new sponsor. At the time 
of the transfer, the new and former owners are required to submit the 
following information to FDA:
    (1) The former owner or assignor of rights shall submit a letter or 
other document that states that all or some rights to the orphan-drug 
designation of the drug have been transferred to the new owner or 
assignee and that a complete copy of the request for orphan-drug 
designation, including any amendments to the request, supplements to the 
granted request, and correspondence relevant to the orphan-drug 
designation, has been provided to the new owner or assignee.
    (2) The new owner or assignee of rights shall submit a statement 
accepting orphan-drug designation and a letter or other document 
containing the following:
    (i) The date that the change in ownership or assignment of rights is 
effective;
    (ii) A statement that the new owner has a complete copy of the 
request for orphan-drug designation including any amendments to the 
request, supplements to the granted request, and correspondence relevant 
to the orphan-drug designation; and
    (iii) A specific description of the rights that have been assigned 
and those that have been reserved. This may be satisfied by the 
submission of either a list of rights assigned and reserved or copies of 
all relevant agreements between assignors and assignees; and
    (iv) The name and address of a new primary contact person or 
resident agent.
    (b) No sponsor may relieve itself of responsibilities under the 
Orphan Drug Act or under this part by assigning rights to another person 
without:
    (1) Assuring that the sponsor or the assignee will carry out such 
responsibilities; or
    (2) Obtaining prior permission from FDA.

[57 FR 62085, Dec. 29, 1992; 58 FR 6167, Jan. 26, 1993]